Label: ASPIRIN tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 67510-0008-1 - Packager: Kareway Product, Inc.
- Category: HUMAN OTC DRUG LABEL
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated November 23, 2011
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient(in each tablet)
- Purposes
- Uses
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Warnings
Reye's syndrome:Children and teenagers should not use this medicine for chicken pox or flu symptoms before a doctor is consulted about Reye's syndrome, a rare but serious illness reported to be associated with aspirin.
Allergy alert:Aspirin may cause a severe allergic reaction which may include:
- hives
- shock
- facial swelling
- asthma (wheezing)
Alcohol warning:
If you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take aspirin or other pain reliever/fever reducers. Aspirin may cause stomach bleeding.
Ask a doctor before use if you have
- stomach problems (such as heartburn, upset stomach, or stomach pain) that last or come back
- bleeding problems
- ulcers
- asthma
Ask a doctor or pharmacist before use if you are
taking a prescription drug for
- anticoagulation (blood thinning)
- gout
- diabetes
- arthritis
Stop use and ask a doctor if
- an allergic reaction occurs. Seek medical help right away.
- new symptoms occur
- pain gets worse or lasts more than 10 days
- redness or swelling is present
- fever lasts more than 3 days
- ringing in the ears or loss of hearing occurs
- Directions
- Other information
- Inactive ingredients
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ASPIRIN
aspirin tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67510-0008 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 325 mg Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) STARCH, CORN (UNII: O8232NY3SJ) Product Characteristics Color white Score no score Shape ROUND Size 10mm Flavor Imprint Code ASPIRIN Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:67510-0008-1 100 in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part343 11/23/2011 Labeler - Kareway Product, Inc. (121840057)